Gravity Flow Technique to Validate Proper Location of Epidural Needle Tip

Not Applicable

Completed

• Conditions: Epidural Anesthesia
• Interventions: Diagnostic Test: Cold Stimulus (ice) Test

• Registration Number: NCT03317626
• Lead Sponsor: NYU Langone Health

Brief Summary

Epidural analgesia for childbirth may fail to provide adequate pain relief. At NYULMC, to maximize the likelihood that epidural analgesia will work well, the gravity flow technique is used when performing epidural procedures.

The gravity flow technique is not well known, and is therefore used in only a few hospitals. The purpose of this study is to quantify the reliability of the gravity flow technique to accurately validate the position of the epidural needle tip when performing lumbar epidural analgesia in laboring women.

Detailed Description

The purpose of this study is to quantify the reliability of the gravity flow technique to accurately validate the position of the epidural needle tip when performing lumbar epidural analgesia in laboring women. This gravity flow technique was first described 26 years ago in 1991, and has been at NYU Langone for 15 years, since 2002. The technique has not been formally studied and this study is designed to enable assessment of the success rate of the gravity flow technique.

Study Timeline

• Study Start: 2017-09-20
• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-23
• Primary Completion: 2018-02-05
• Study Completion: 2018-02-05
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-13
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Patients requesting epidural analgesia for labor
• ASA physical status I to II
• Ability to speak and read English to fully comprehend the consent process

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Exclusion Criteria

• Combined spinal-epidural anesthesia
• Coagulopathy
• History of lumbar spine surgery
• Allergy or contraindication to any of the study medications
• Contraindication to epidural analgesia
• ASA physical status >III

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cold Stimulus	Cold Stimulus (ice) Test	The study procedure will beto use a coldstimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen at 15 minutes and if necessary at 30 minutes after the epidural is inserted

Primary Outcome Measures

Name	Time	Method
Accurate validation of the position of the epidural needle tip whenperforming lumbar epidural analgesia in laboring women.	30 Minutes post intervention	Success will be defined as a bilateral decrease of sensation (hypesthesia) to cold and ice in at least 2 adjacent dermatomes between T8 and L2

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States